Infectious Diseases News Alerts

• Alert FDA OKs Quadrivalent, Adjuvanted Flu Vaccine for Older Adults The quadrivalent version of Fluad was safe and effective against influenza strains included in the vaccine in multiple clinical studies with adults aged 65 years or older.
  News Alerts, February 24, 2020
• Alert CDC Confirms 13th Case of Coronavirus in US The latest case was a person in California who was previously under federal quarantine because of travel to Wuhan, China. Lab results initially indicated that the patient was negative for COVID-19.
  Medscape Medical News, February 11, 2020
• Alert ACIP Releases 2020 Child and Adolescent Vaccine Schedule Changes include a recommendation for a hepatitis A catch-up vaccination for anyone who wasn't vaccinated as a child.
  News Alerts, February 04, 2020
• Alert FDA Approves Novel Pandemic Influenza Vaccine Audenz (Seqirus) is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
  FDA Approvals, February 03, 2020
• Alert ACIP Updates Recommendations for Adult Vaccines The ACIP's 2020 guidelines include updated instructions for nuanced shared clinical decision making in certain scenarios.
  News Alerts, February 03, 2020
• Alert EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for Vaxchora recombinant, live, oral cholera vaccine.
  International Approvals, January 31, 2020
• Alert WHO Declares Public Health Emergency for Novel Coronavirus The declaration was made after a week of growing concern and pressure on WHO officials to designate the virus at a higher emergency level. The Emergency Committee's decision was nearly unanimous.
  Medscape Medical News, January 30, 2020
• Alert FDA OKs Fidaxomicin for C difficile in Children The macrolide antibacterial is now approved in oral suspension and tablets for treatment of Clostridioides difficile-associated diarrhea (CDAD) in children aged 6 months and older.
  FDA Approvals, January 27, 2020
• Alert US Gets First Case of Mysterious Chinese Coronavirus A Washington state man returning from Wuhan, the outbreak's epicenter, was hospitalized in good condition. The newly discovered virus can cause coughing, fever, breathing difficulty, and pneumonia.
  Associated Press, January 21, 2020
• Alert FDA Expands Use of Antifungal Micafungin (Mycamine) to Newborns The FDA has approved the use of micafungin sodium to treat invasive candidiasis in children younger than 4 months of age.
  FDA Approvals, January 09, 2020
• Alert FDA OKs First Vaccine Against Deadly Ebola Virus The live (attenuated) Ervebo vaccine protects against Ebola virus disease caused by the Zaire strain of the Ebola virus is approved in people 18 and older.
  FDA Approvals, December 20, 2019
• Alert FDA Clears First Fully Disposable Duodenoscope Availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, the FDA says.
  FDA Approvals, December 16, 2019
• Alert EMA Panel Endorses Antibacterial Drug Trio Recarbrio Recarbrio combines imipenem, cilastatin, and relebactam and is for the treatment of infections due to aerobic Gram-negative pathogens in adults with limited treatment options.
  International Approvals, December 16, 2019
• Alert FDA Clears Faster Diagnostic Test for MRSA The cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in 5 hours or less compared with 24 to 48 hours for conventional cultures.
  FDA Approvals, December 05, 2019
• Alert FDA OKs First System for In-Office Tympanostomy Tube Placement The Tubes Under Local Anesthesia (Tula, Tusker Medical) system uses a small electrical current to deliver a local anesthetic into the ear drum prior to tube insertion in the outpatient setting.
  FDA Approvals, November 26, 2019
• Alert FDA OKs New Antibacterial Cefiderocol for Complicated UTI Last month, an FDA panel recommended approval of cefiderocol for treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by Gram-negative bacteria.
  FDA Approvals, November 15, 2019
• Alert FDA Clears Next-Gen Assay to Detect HIV-1 Drug Resistance The Sentosa SQ HIV genotyping assay is the first HIV drug resistance assay that uses next generation sequencing technology that the FDA has authorized for use.
  FDA Approvals, November 06, 2019
• Alert FDA OKs Fluzone High-Dose Influenza Vaccine for Older Adults Sanofi will transition completely from the trivalent to quadrivalent Fluzone high-dose influenza vaccines in the US. The quadrivalent vaccine will be available for the 2020-2021 flu season.
  FDA Approvals, November 05, 2019
• Alert FDA OKs First Rifabutin-Based H pylori Therapy Talicia Talicia combines omeprazole, amoxicillin, and rifabutin and is designed to address growing bacterial resistance to standard clarithromycin-based H pylori therapy.
  FDA Approvals, November 04, 2019
• Alert EMA Updates Advice on Risk of Blood Clots With Tofacitinib The EMA safety committee says tofacitinib should be used with caution in all patients at high risk for blood clots.
  News Alerts, October 31, 2019